KeratoconusPhase 2/3NCT07841470
Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia
A Phase 2/3 study testing Riboflavin 0.1% ophthalmic solution and pulsed light and Riboflavin 0.1% ophthalmic solution and non-pulsed light in people with Keratoconus and Corneal Ectasia, run by Price Vision Group at 1 site in United States.
Trial summary
This randomized study compares 2 variations of corneal crosslinking for treatment of keratoconus or corneal ectasia. Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Keratoconus, Corneal Ectasia
- What is being tested?
- Riboflavin 0.1% ophthalmic solution and pulsed light and Riboflavin 0.1% ophthalmic solution and non-pulsed light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 30 Jun 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of keratoconus or corneal ectasia
- Provision of written informed consent
Who cannot join
- Previous ocular condition in the study eye that may predispose for future complications including history of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
- Clinically significant corneal scarring in the proposed treatment zone
- History of chemical injury or delayed epithelial healing in the study eye
- Known sensitivity to study medication
- A current condition, including clinically significant dry eyes or use of medications know to induce dry eye symptoms, that, in the treating physician's opinion, would interfere with or prolong epithelial healing
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Price Vision Group
Indianapolis, Indiana, 46260
Marianne Price, PhD, 317-814-2990, mprice@cornea.org
About this study
Official title: Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia: Randomized Comparison of Pulsed vs. Non-pulsed Treatment
This randomized study compares 2 variations of corneal crosslinking for treatment of keratoconus or corneal ectasia.
Read the detailed description
Subjects diagnosed with keratoconus or corneal ectasia are randomized to one of two corneal crosslinking light durations.
- Conditions
- Keratoconus, Corneal Ectasia
- Being tested
- Riboflavin 0.1% ophthalmic solution and pulsed light, Riboflavin 0.1% ophthalmic solution and non-pulsed light
- Keywords
- crosslinking, keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riboflavin 0.1% ophthalmic solution and pulsed lightCombination product
Use of riboflavin 0.1% eye drops and pulsed 18 milliwatt/cm2 ultraviolet A light for 10 minutes
Riboflavin 0.1% ophthalmic solution and non-pulsed lightCombination product
Use of riboflavin 0.1% eye drops and non-pulsed 9 milliwatt/cm2 ultraviolet A light for 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Pulsed | Active comparator | Treatment with 0.1% riboflavin eye drops and pulsed 18 milliwatt/cm2 ultraviolet A light for 10 minutes Receives: Combination Product: Riboflavin 0.1% ophthalmic solution and pulsed light |
| Non-pulsed | Active comparator | Treatment with 0.1% riboflavin eye drops non-pulsed 9 milliwatt/cm2 ultraviolet A light for 10 minutes Receives: Combination Product: Riboflavin 0.1% ophthalmic solution and non-pulsed light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum keratometry
assessed with corneal tomography
Measured: 6 months
Secondary outcomes (2)
change in corrected distance visual acuity
assessed with Snellen chart
Measured: 6 months
change in uncorrected distance visual acuity
assessed with Snellen chart
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Oct 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Price Vision Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francis Price, MD, Principal investigator, Price Vision Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841470
- Sponsor's protocol ID
- 2025-001
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD may be shared upon individual request to the study contact
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia: Randomized Comparison of Pulsed vs. Non-pulsed Treatment
- ClinicalTrials.gov ID
- NCT07841470
- Acronym / sponsor ID
- 2025-001
- Conditions
- Keratoconus, Corneal Ectasia
- Keywords
- crosslinking, keratoconus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Price Vision GroupIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized study compares 2 variations of corneal crosslinking for treatment of keratoconus or corneal ectasia.
Detailed description
Subjects diagnosed with keratoconus or corneal ectasia are randomized to one of two corneal crosslinking light durations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed | Active comparator | Combination Product: Riboflavin 0.1% ophthalmic solution and pulsed lightTreatment with 0.1% riboflavin eye drops and pulsed 18 milliwatt/cm2 ultraviolet A light for 10 minutes |
| Non-pulsed | Active comparator | Combination Product: Riboflavin 0.1% ophthalmic solution and non-pulsed lightTreatment with 0.1% riboflavin eye drops non-pulsed 9 milliwatt/cm2 ultraviolet A light for 10 minutes |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of keratoconus or corneal ectasia
- Provision of written informed consent
Key exclusion criteria (6 listed)
- Previous ocular condition in the study eye that may predispose for future complications including history of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
- Clinically significant corneal scarring in the proposed treatment zone
- History of chemical injury or delayed epithelial healing in the study eye
- Known sensitivity to study medication
- A current condition, including clinically significant dry eyes or use of medications know to induce dry eye symptoms, that, in the treating physician's opinion, would interfere with or prolong epithelial healing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Riboflavin 0.1% ophthalmic solution and pulsed lightUse of riboflavin 0.1% eye drops and pulsed 18 milliwatt/cm2 ultraviolet A light for 10 minutes | Combination product | Pulsed |
| Riboflavin 0.1% ophthalmic solution and non-pulsed lightUse of riboflavin 0.1% eye drops and non-pulsed 9 milliwatt/cm2 ultraviolet A light for 10 minutes | Combination product | Non-pulsed |
Primary outcome
Change in maximum keratometry
Time frame: 6 months
assessed with corneal tomography
2 secondary outcomes
change in corrected distance visual acuity
Time frame: 6 months
change in uncorrected distance visual acuity
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. IPD may be shared upon individual request to the study contact
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francis Price, MD principal investigator
Price Vision Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Riboflavin 0.1% ophthalmic solution and pulsed light and Riboflavin 0.1% ophthalmic solution and non-pulsed light in people with Keratoconus and Corneal Ectasia, run by Price Vision Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marianne Price, PhD (317-814-2990, mprice@cornea.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximum keratometry (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.